|

Randomized, Single-blind Pilot Study Assessing the Effect of Cutaneous RESonance Stimulation SYMPAthetic and Parasympathetic Tone and Anxiety in Patients Admitted for Cardiac Surgery

RECRUITINGSponsored by Hospices Civils de Lyon
Actively Recruiting
SponsorHospices Civils de Lyon
Started2025-09-30
Est. completion2027-03-03
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

Anxiety is a natural response to stress which peaks just before the surgery procedure. High levels of anxiety can increase postoperative pain and complications. Medicated anxiolysis is no longer recommended, in the absence of proven efficacy. Other interventions to prevent anxiety are required. The autonomic nervous system (ANS), both sympathetic and parasympathetic, determines the response to stress. Anxiety interventions such as hypnosis, massage and relaxation work by modulating ANS tone. The ANS also modulates heart rate. Anxiety can be measured by RR space, from which HRV, high-frequency (HF) and low-frequency (LF) are components respectively linked to the parasympathetic and sympathetic systems. The LF/HF ratio reflects sympathetic dominance if high, and parasympathetic dominance if low. Cutaneous resonance stimulation (RESC) is a manual technique. RESC can diagnose and correct energy imbalances by skin stimulation between two points and thus act on anxiety. We hypothesized that a preoperative RESC session would modify the sympathetic/parasympathetic balance and reduce anxiety in patients admitted for cardiac surgery, compared to patient receiving a sham RESC session: non-specific cutaneous stimulation (NSCS).

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Planned cardiac surgery with extracorporeal circulation
* Pre operatory anxiety : STAI-E score \>30 or Visual Analogue Scale Anxiety \>6

Exclusion Criteria:

* Urgent surgery
* Atrial fibrillation
* Impossibility to answer to STAI-E or VAS
* Use of alternative method
* Use of an alternative method other for anxiety before inclusion
* Absence of consent
* Pregnant, breastfeeding women.

Conditions2

AnxietyHeart Disease

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.